510(k) · Cleared
ClearedMammotome Biopsy Probe and Housing (Mammotome)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopsys Medical, Inc. · KNW Instrument, Biopsy
Cleared on Mar 28, 1997 after a 43-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 43 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK970565 Mammotome Biopsy Probe and Housing (Mammotome)Biopsys Medical, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK024089 Vacuflash Biopsy SystemBip USA, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK053151 Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK071048 Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU…Transmed7, LLC · 2018
- Descendant · 4 generations on · 0 of its ownK133702 Presto Breast Biopsy DeviceSontina Medical, LLC · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K024089Vacuflash Biopsy SystemBip USA, Inc. · 2003 · cites it directly4descendants
- K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc. · 2005 · 2 generations on3descendants
- K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007 · 3 generations on1descendant
- K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC · 2018 · 2 generations on0descendants
- K133702Presto Breast Biopsy DeviceSontina Medical, LLC · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970565 | Mammotome Biopsy Probe and Housing (Mammotome) | Biopsys Medical, Inc. | 1997 | — |
| +1 | K024089 | Vacuflash Biopsy System | Bip USA, Inc. | 2003 | — |
| +2 | K053151 | Rubicor Magic Breast Biopsy Device | Rubicor Medical, Inc. | 2005 | — |
| +3 | K071048 | Rubicor Magic Breast Biopsy Device, Model 31537 | Rubicor Medical, Inc. | 2007 | — |
| +2 | K173316 | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft… | Transmed7, LLC | 2018 | — |
| +4 | K133702 | Presto Breast Biopsy Device | Sontina Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Biopsys Medical Needle Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K024089 (Bip USA, Inc., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970565: Mammotome Biopsy Probe and Housing (Mammotome).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970565
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026